LAKES: Color additive lakes are provisionally listed under 21 CFR 81.1. Part 82 of 21 CFR explains how lakes may be manufactured and named and lists the color additives that may be used to manufacture lakes. All lakes are subject to certification.
Examples of nomenclature of lakes:
- The name of a lake is formed from the name of the color additive combined with the name of the basic radical and the word "Lake". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon alumina would be FD&C Blue No. 1 - Aluminum Lake.
- If a lake is prepared by extending an FD&C color additive on a substratum other than alumina, the symbol "FD&C" will be replaced by "D&C". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon a substratum other than alumina would be D&C Blue No. 1- Aluminum Lake.
Color additives subject to certification and permanently listed (unless otherwise indicated) for use in FOOD. Most are also listed for use in DRUGS AND COSMETICS as noted. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated).
- FD&C Blue #1 - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP - 74.101, 74.1101, 74.2101, 82.101
- FD&C Blue #1 Aluminum Lake - Drugs and cosmetics for eye area - GMP - 74.1101, 74.2101, 82.101
- FD&C Blue #2 - Food and ingested drugs - GMP - 74.102, 74.1102; sutures - see medical devices - 74.3102.
- FD&C Blue #2 Aluminum Lake on alumina - Bone cement - see medical devices - 74.3102, 82.102
- FD&C Green #3 - Food, drugs and cosmetics - GMP - 74.203, 74.1203, 74.2203, 82.203
- FD&C Red #3 - Food and ingested drugs - GMP - 74.303, 74.1303. May no longer be used in cosmetics, external drugs, and lakes
- FD&C Red #40 and its Aluminum Lake - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP. Other lakes for food, drugs and cosmetics are also permanently listed - 74.340, 74.1340, 74.2340
- FD&C Yellow #5 - Food, drugs and cosmetics, including drugs and cosmetics for eye area - GMP - 74.705, 74.1705, 74.2705, 82.705
- FD&C Yellow #5 Aluminum Lake - Drugs and cosmetics for eye area - GMP - 74.1705, 74.2705, 82.705
- FD&C Yellow #6 - Food, drugs and cosmetics - GMP - 74.706, 74.1706, 74.2706, 82.706
- FD&C Lakes (See Preface of this exhibit) - Provisionally listed. May be prepared from any of the above certified FD&C colors, except FD&C Red #3 - GMP - 81.1, 82.51
- Citrus Red #2 - Skins of mature oranges - ≤ 2 ppm by wt. of whole fruit - 74.302 Orange B - Surfaces and casings of frankfurters or sausages - ≤ 150 ppm by wt. of finished product - 74.250
Use of the following color additives is no longer authorized or has been restricted:
- FD&C Green #1 - Removed from list - 81.30(d)
- FD&C Green #2 - Removed from list - 81.30(d)
- FD&C Red #1 - Removed from list - 81.10(c), 81.30(b)(1)
- FD&C Red #2 - Removed from list - 81.10(f), Feb. 13, 1976 - 81.30(j)
- FD&C Red #3 - All lakes, all cosmetics, and external drugs removed from list - 81.10(u), Feb. 1, 1990 - 81.30(u). Use of FD&C Red #3, but not its lakes, in food and ingested drugs is allowed.
- FD&C Red #4 - Food, ingested drugs, and ingested cosmetics removed from list. Use in externally applied drugs and cosmetics is allowed - 81.10(d), Sep. 23, 1976 - 81.30(c).
- FD&C Violet #1 - Removed from list - 81.10(e), Apr. 10, 1973 - 81.30(h)
Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye unless otherwise indicated)
- D&C Black #2 - Only for the following cosmetics: eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel - GMP - 74.2052
- D&C Black #3 - Only for the following cosmetics: eyeliner, eye shadow, mascara, and face powder. - GMP - 74.2053
- D&C Green #5 - For drugs and cosmetics including drugs and cosmetics for eye area - GMP - 74.1205, 74.2205, 82.1205
- D&C Orange #5 - Drugs: mouthwashes and dentifrices that are ingested drugs (GMP), and external drugs (at most 5 mg per day). Cosmetics: lipsticks (at most 5% by wt. of finished product), mouthwashes and dentifrices that are ingested cosmetics, and external cosmetics (GMP) 74.1255, 74.2255, 82.1255
- D&C Red #6 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 < 5 mg per day); For cosmetics (GMP) -74.1306, 74.2306, 82.1306
- D&C Red #7 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 < 5 mg per day); For cosmetics (GMP) -74.1307, 74.2307, 82.1307
- D&C Red #21 - For drugs generally and cosmetics - GMP -74.1321, 74.2321, 82.1321
- D&C Red #22 - For drugs generally and cosmetics - GMP -74.1322, 74.2322, 82.1322
- D&C Red #27 - For drugs generally and cosmetics - GMP -74.1327, 74.2327, 82.1327
- D&C Red #28 - For drugs generally and cosmetics - GMP -74.1328, 74.2328, 82.1328
- D&C Red #30 - For drugs generally and cosmetics - GMP -74.1330, 74.2330, 82.1330
- D&C Red #33 - Drugs: ingested drugs other than mouthwashes and dentifrices (at most 0.75 mg per day); and mouthwashes, dentifrices, and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product); and mouthwashes, dentifrices and external cosmetics (GMP) 74.1333, 74.2333, 82.1333
- D&C Red #36 - Drugs: ingested drugs, other than mouthwashes and dentifrices, if taken continuously for < 1 year (at most 1.7 mg per day); ingested drugs if taken continuously for > 1 year (at most 1.0 mg per day); and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product), and external cosmetics (GMP) 74.1336, 74.2336, 82.1336
- D&C Yellow #10 - For drugs generally and cosmetics -GMP -74.1710, 74.2710, 82.1710
- D&C Lakes (See Preface of this Exhibit) - Provisionally listed. May be prepared from any of the FD&C or D&C color additives listed in part 82
Use of the following color additives is no longer authorized or has been restricted:
- D&C Black #1 - Sep. 4, 1966 - 81.30(d)
- D&C Blue #6 - Use in drugs and cosmetics is no longer authorized. 81.10(n); use in sutures is allowed (Dec. 13, 1977) - 81.30(o)
- D&C Blue #7 - Sep. 4, 1966 - 81.30(d)
- D&C Green #6 - Use in ingested drugs and ingested cosmetics is no longer authorized Mar. 27, 1981 - 81.10(o). Use in external drugs external cosmetics, and sutures is allowed
- D&C Green #7 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #3 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #8 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #10 - Use in ingested drugs and ingested cosmetics is no longer authorized - 81.10(m), Apr. 28, 1981 - 81.30(n). Use in external drugs and external cosmetics is allowed
- D&C Orange #11 - Use in ingested drugs and ingested cosmetics is no longer authorized - 81.10(m), Apr. 28, 1981 - 81.30(n). Use in external drugs and external cosmetics is allowed
- D&C Orange #14 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #15 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #16 - Sep. 4, 1966 - 81.30(d)
- D&C Orange #17 - Removed from list Mar. 31, 1983 - 81.10(s)
- D&C Red #5 - Sep. 4, 1966 - 81.30(d)
- D&C Red #8 - Removed from list Jan. 6, 1987 - 81.10(t), 81.30(s)(1); July 15, 1988 - 81.30(s)(3)
- D&C Red #9 - Removed from list Jan. 6, 1987 - 81.10(t), 81.30(s)(1); July 15, 1988 - 81.30(s)(3)
- D&C Red #10 - Removed from list Dec. 13, 1977 - 81.10(h), 81.30(k)
- D&C Red #11 - Removed from list Dec. 13, 1977 - 81.10(h), 81.30(k)
- D&C Red #12 - Removed from list Dec. 13, 1977 - 81.10(h), 81.30(k)
- D&C Red #13 - Removed from list Dec. 13, 1977 - 81.10(h), 81.30(k)
- D&C Red #14 - Sep. 4, 1966 - 81.30(d)
- D&C Red #18 - Sep. 4, 1966 - 81.30(d)
- D&C Red #19 - Removed from list Feb. 4, 1983 - 81.10(q)(1)
- D&C Red #24 - Sep. 4, 1966 - 81.30(d)
- D&C Red #29 - Sep. 4, 1966 - 81.30(d)
- D&C Red #35 - Sep. 4, 1966 - 81.30(d)
- D&C Red #37 - Removed from list Feb 4, 1983 and June 6, 1986 - 81.10(q)
- D&C Red #38 - Sep. 4, 1966 - 81.30(d)
Color Additives subject to certification and permanently listed (unless otherwise indicated) for use in EXTERNALLY APPLIED DRUGS & COSMETICS. (None of these colors may be used in products that are for use in the area of the eye)
- D&C Brown #1 Only external cosmetics - GMP - 74.2151
- FD&C Red #4 - For use only in externally applied drugs and cosmetics - GMP - 74.1304, 74.2304, 82.304
- D&C Red #17 - GMP - 74.1317, 74.2317, 82.1317
- D&C Red #31 - GMP - 74.1331, 74.2331, 82.1331
- D&C Red #34 - GMP - 74.1334, 74.2334, 82.1334
- D&C Red #39 - Only as an external drug in quaternary ammonium germicidal solutions (at most 0.1% by wt. of the finished product) 74.1339
- D&C Violet #2 - External drugs and cosmetics (GMP) and contact lenses, sutures, haptics and tacks (see medical devices) 74.1602, 74.2602, 82.1602
- Ext. D&C Violet #2 - For external cosmetics only - GMP -74.2602a
- D&C Blue #4 - GMP - 74.1104, 74.2104, 82.1104
- D&C Green #6 - GMP - 74.1206, 74.2206, 82.1206
- D&C Green #8 - Limit ≤ 0.01% by wt of finished drug or cosmetic - 74.1208, 74.2208
- D&C Yellow #7 - GMP - 74.1707, 74.2707, 82.1707
- Ext. D&C Yellow #7 - GMP - 74.1707a, 74.2707a, 82.2707a
- D&C Yellow #8 - GMP - 74.1708, 74.2708, 82.1708
- D&C Yellow #11 - GMP - 74.1711, 74.2711
- D&C Orange #4 - GMP - 74.1254, 74.2254, 82.1254
- D&C Orange #10 - GMP - 74.1260, 74.2260, 82.1260
- D&C Orange #11 - GMP - 74.1261, 74.2261, 82.1261
- Ext. D&C Lakes (See Preface of this Exhibit) - The only permitted Ext. D&C lake is Ext. D&C Yellow No. 7 lake prepared from Ext. D&C Yellow No. 7 (GMP) 81.1, 82.2051, 82.2707a
Use of the following color additives is no longer authorized:
- Ext. D&C Blue #1 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #11 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Blue #4 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #13 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Green #1 - Nov. 29, 1977 - 81.10(k)
- Ext. D&C Red #14 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Orange #1 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #15 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Orange #3 - Jul. 1, 1968 - 81.30(e)
- Ext. D&C Yellow #1 - Dec. 13, 1977 - 81.10(i)
- Ext. D&C Orange #4 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #1 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Yellow #3 - Jul. 1, 1968 - 81.30(e)
- Ext. D&C Red #2 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Yellow #5 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #3 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Yellow #6 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Red #8 - Jul. 1, 1968 - 81.30(e)
- Ext. D&C Yellow #9 - 81.10(a)
- Ext. D&C Red #10 - Sep. 4, 1966 - 81.30(d)
- Ext. D&C Yellow #10 - 81.10(a)
Color additives exempt from certification and permanently listed for FOOD use.
- Algae meal, dried - Chicken feed only: ≤ 0.3% ethoxyquin in meal ≤ 150 ppm ethoxyquin in final feed - 73.275
- Annatto extract - GMP - 73.30
- Astaxanthin - Salmonid fish feed only: ≤ 80 mg per kg of finished feed - 73.35
- Astaxanthin dimethyldisuccinate - Salmonid fish feed only: ≤ 80 mg per kg of finished feed - 73.37
- Beet juice (as vegetable juice) - GMP - 73.260
- Beet powder (Dehydrated beets) - GMP - 73.40
- Beta-Apo-8'-carotenal - General use: ≤ 15 mg/lb of solid or semisolid food or per pint of liquid food - 73.90
- Beta carotene, natural and synthetic - GMP - 73.95
- Canthaxanthin - General use: ≤ 30 mg/lb of solid or semisolid food or per pint of liquid food; broiler chicken feed: ≤ 4.41 mg per kg (4 gm/ton) of complete feed; salmonid fish feed: ≤ 80 mg per kg (72 gm/ton) of finished feed - 73.75
- Caramel - GMP - 73.85
- Carmine - GMP - 73.100
- Carrot oil - GMP - 73.300
- Cochineal extract - GMP - 73.100
- Corn endosperm oil - Chicken feed only - 73.315
- Cottonseed flour, toasted partially defatted cooked - GMP - 73.140
- Ferrous gluconate -Ripe olives only - GMP -73.160
- Ferrous lactate - Ripe olives only - GMP - 73.165
- Fruit juice - GMP - 73.250
- Grape color extract - Nonbeverage food only - 73.169
- Grape skin extract (enocianina) - Still and carbonated drinks and ades, beverage bases and alcoholic beverages (in accordance with Parts 4 & 5 of 27 CFR) - 73.170
- Haematococcus algae meal - Salmonid fish feed only. Total astaxanthin from all astaxanthin color additive sources listed in part 73, ≤ 80 mg per kg of finished feed - 73.185
- Synthetic iron oxide - Sausage casings for humans: ≤ 0.10% by wt. of finished food; Hard and soft candy, mints and chewing gum - GMP; Pb spec. ≤ 5 ppm; cat & dog food: ≤ 0.25% by wt of finished food - 73.200
- Lycopene, tomato extract or concentrate - GMP - 73.585
- Mica-based pearlescent pigment - 1.25% by weight in cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. In amounts up to 0.07 % by weight in distilled spirits containing not less than 18 % and not more than 25% alcohol by volume, cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, and nonalcoholic cocktail mixers and mixes. In egg decorating kits used for coloring the shells of eggs in amounts consistent with GMP - 73.350
- Paprika & Paprika oleoresin - GMP - 73.340 & 73.345
- Paracoccus pigment - Salmonid fish feed only: ≤ 80 mg per kg of finished feed - 73.352
- Phaffla yeast - Salmonid fish feed only. Total astaxanthin from all astaxanthin color additive sources listed in part 73, ≤ 80 mg per kg of finished feed - 73.355
- Riboflavin - GMP - 73.450
- Saffron - GMP - 73.500
- Sodium copper chlorophyllin - Citrus-based dry beverage mixes only: ≤ 0.2 percent by wt. of the dry mix - 73.125
- Spirulina extract – to color confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals), at levels consistent with GMPs, except that it may not be used to color foods for which standards of identity have been issued unless the use of added color is authorized by such standards – 73.530
- Tagetes (Aztec marigold) meal and extract - Chicken feed only: ethoxyquin content ≤ 0.3% by wt. of additive and ≤ 150 ppm by wt. of final feed - 73.295
- Titanium dioxide - ≤ 1.0% by wt. of food - 73.575
- Turmeric & Turmeric oleoresin - GMP - 73.600 & 73.615
- Ultramarine blue - Salt for animal feed only: ≤ 0.5% by wt. of salt - 73.50
- Vegetable juice - GMP - 73.260
Use of the following color additives is no longer authorized:
- Alkanet (Alkane)
- Calcium carbonate - Allowed in drugs
- Carbon black
- Charcoal - NF XI
- Cudbear
- Ferric chloride
- Ferrous sulfate
- Logwood, chips & extract - Logwood extract is still permitted in sutures
- Safflower (American saffron)
Color additives exempt from certification and permanently listed for DRUG use. (None of these color additives may be used in products that are for use in the area of the eye, unless otherwise indicated.).
- Alumina - Drugs generally - GMP - 73.1010
- Aluminum powder - Externally applied drugs, including those for eye area use - GMP - 73.1645
- Annatto extract - Drugs generally, including those for eye area use - GMP - 73.1030
- Beta-carotene, natural and synthetic - Drugs generally, including those for eye area - GMP - 73.1095
- Bismuth oxychloride - Externally applied drugs only, including those for eye area - GMP - 73.1162
- Bronze powder - Externally applied drugs only, including those for eye area - GMP - 73.1646
- Calcium carbonate - Drugs generally - GMP - 73.1070
- Canthaxanthin - GMP - Ingested drugs only - 73.1075
- Caramel - Drugs generally - GMP - 73.1085
- Carmine - Drugs generally - GMP - 73.1100
- Chlorophyllin, copper complex - Dentrifices that are drugs - ≤ 0.1% by wt. - 73.1125
- Chromium hydroxide, green - Externally applied drugs, including those for eye area - GMP - 73.1326
- Chromium oxides greens - Externally applied drugs, including those for eye area - GMP - 73.1327
- Cochineal extract - Drugs generally - GMP - 73.1100
- Copper, metallic powder - Externally applied drugs, including those for eye area - GMP - 73.1647
- Potassium sodium copper chlorophyllin (Chlorophyllin copper complex) - Dentifrices that are drugs - ≤ 0.1% by wt. - 73.1125
- Dihydroxyacetone - Externally applied drugs intended to impart a color to the human body - GMP - 73.1150
- Ferric ammonium ferrocyanide (Iron Blue) - Externally applied drugs, including those for eye area - GMP - 73.1298
- Ferric ferrocyanide (Iron Blue) - Externally applied drugs, including those for eye area - GMP - 73.1299
- Guanine (Pearl essence) - Externally applied drugs, including those for eye area - GMP - 73.1329
- Mica - Dentifrices and externally applied drugs, including those for eye area - GMP - 73.1496
- Mica-based pearlescent pigment - 3% by weight of drug; Iron nte 55 % pigment - 73.1128
- Pyrophyllite - Externally applied drugs - GMP - 73.1400
- Synthetic iron oxide - Drugs generally. Limit for ingested drugs ≤ 5 mg elemental iron per day - 73.1200
- Talc - Drugs generally - GMP - 73.1550
- Titanium dioxide - Drugs generally, including those for eye area - GMP - 73.1575
- Zinc oxide - Externally applied drugs, including those for eye area - GMP - 73.1991
Use of the following color additives is no longer authorized:
- Bone Black
- Charcoal NF XI
- Chlorophyll copper complex
- Fustic
- Ultramarine blue - use in cosmetics is allowed
Color additives exempt from certification and permanently listed for COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated)
- Aluminum powder - Externally applied cosmetics, including those for eye area - GMP - 73.2645
- Annatto - Cosmetics generally, including those for eye area - GMP - 73.2030
- Bismuth citrate - For cosmetics intended to color hair on scalp only (Not for coloring eyelashes or eyebrows or other body hair) - ≤ 2.0% (wt/v) - 73.2110
- Bismuth oxychloride - Cosmetics generally, including those for eye area - GMP - 73.2162
- Bronze powder - Cosmetics generally, including those for eye area - GMP - 73.2646
- Caramel - Cosmetics generally, including those for eye area - GMP - 73.2085
- Carmine - Cosmetics generally, including those for eye area - GMP - 73.2087
- Beta-carotene - Cosmetics generally, including those for eye area - GMP - 73.2095
- Chromium hydroxide green - Externally applied cosmetics, including those for eye area - GMP - 73.2326
- Chromium oxide greens - Externally applied cosmetics, including those for eye area - GMP - 73.2327
- Copper, metallic powder - Cosmetics generally, including those for eye area - GMP - 73.2647
- Dihydroxyacetone - Externally applied cosmetics - GMP - 73.2150
- Disodium EDTA-copper - Cosmetic shampoos - GMP - 73.2120
- Ferric ammonium ferrocyanide - Externally applied cosmetics, including those for eye area - GMP - 73.2298
- Ferric ferrocyanide - Externally applied cosmetics, including those for eye area - GMP - 73.2299
- Guaiazulene (Azulene) - Externally applied cosmetics - GMP - 73.2180
- Guanine (Pearl essence) - Cosmetics generally, including those for eye area - GMP - 73.2329
- Henna - For coloring hair only, not for coloring eyelashes or eyebrows - 73.2190
- Iron oxides - Cosmetics generally, including those for eye area - GMP - 73.2250
- Lead acetate - For coloring hair only, not for coloring mustaches, eyelashes, eyebrows or other body hair. Limit ≤ 0.6% (wt/v) - 73.2396
- Luminescent zinc sulfide - Externally applied cosmetics (nail polish and facial) - 73.2995
- Manganese Violet - Cosmetics generally, including those for eye area - GMP - 73.2775
- Mica - Cosmetics generally, including those for eye area - GMP - 73.2496
- Potassium sodium copper chlorophyllin (Chlorophyllin copper complex) - Cosmetic dentifrices - ≤ 0.1% by wt. May be used only in combination with the substances listed in 21 CFR 73.2125(b)(2) - 73.2125
- Pyrophyllite - Externally applied cosmetics - GMP -73.2400
- Silver - Fingernail polish - ≤ 1% by wt. - 73.2500
- Titanium dioxide - Cosmetics generally, including those for eye area - GMP - 73.2575
- Ultramarines (Blue, Green, Pink, Red & Violet) - Externally applied cosmetics, including those for eye area - GMP - 73.2725
- Zinc oxide - Cosmetics generally, including those for eye area - GMP - 73.2991
Use of the following color additives is no longer authorized:
- Alloxan
- Bone black
- Carbon black (channel process)
- Carminic acid
- Chlorophyll copper complex
- Cobaltous aluminate (Cobalt Blue)
- Cochineal
- Fuller's earth
- Gloss white
- Graphite
- Kieselguhr (Diatomite)
- Lithopone
- Logwood (Gluewood, Campeche wood)
- 4-Methyl-7-diethylaminocoumarin (MDAC)
- B-Methyl umbelliferone
- Potassium ferrocyanide
- Sienna
- Umber
- Vermiculite
- Zirconium oxide
- Zirconium silicate